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Government Accountability Office, Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain Types of Devices (GAO-12-816) (Aug. 31, 2012) (full-text).


In this report, the GAO (1) identifies the threats, vulnerabilities, and resulting information security risks associated with active implantable medical devices, (2) determines the extent to which the FDA considered information security during its premarket review of certain devices with known vulnerabilities, and (3) determines what postmarket efforts the FDA has in place to identify information security problems.